Clinical trials: Comprehension unaffected by simplified consent forms or payment

August 10, 2010

(Garrison, NY) Although informed consent is an ethical cornerstone in research with humans, some studies suggests that volunteers often do not understand key aspects of the research in which they participate. Recent efforts have been made to improve informed consent by simplifying the consent forms.

A new study refutes two common assumptions about consent forms: that the length and complexity of forms affect comprehension and that people who are paid to enroll in research may be "blinded by money" and thus ignore key details of the study.

In a randomized controlled trial of a standard versus concise consent form for a low-risk phase I bioequivalence study of a marketed drug, the authors found that overall comprehension was comparable - and high - with both forms. Furthermore, the shorter form appeared to have no adverse effect on the quality of informed consent. Another intriguing finding was that comprehension was slightly higher among the paid volunteers than those who were unpaid. And, the study revealed that the overall comprehension scores of socioeconomically disadvantaged participants was good, negating the common claim that this population of research participants requires special protections.

The report of the study appeared in IRB: Ethics & Human Research, published by The Hastings Center. The authors include two Hastings Center Fellows and bioethics leaders in the federal government: Ezekiel Emanuel, head of the Department of Bioethics at the National Institutes of Health Clinical Center and special advisor for health policy to the director of the White House Office of Management and Budget; and Christine Grady, acting chief of the Department of Bioethics at the NIH Clinical Center and a member of the Presidential Commission for the Study of Bioethical Issues. Other authors are Leanne Stunkel and Ninet Sinaii, of the NIH Department of Bioethics; and Meredith Benson, Louise McLellan, and Garbriella Bedarida, of Pfizer.

Although informed consent is an ethical cornerstone in research with humans, some studies suggest that volunteers often don't understand key aspects of the research. Recent efforts have been made to improve informed consent by simplifying the consent forms. A new study refutes two common assumptions about consent forms: that the length and complexity of forms affect comprehension and that people who are paid to enroll in research may be "blinded by money" and thus ignore key details of the study.
-end-


The Hastings Center

Related Bioethics Articles from Brightsurf:

Unknowns and uncertainties raise ethical concerns for UK egg freezing
A lack of clear, accessible, and transparent data creates a series of ethical issues for egg freezing, according to a new briefing note from the Nuffield Council on Bioethics.

Tackling the bioethics challenges raised by COVID-19
The diverse situations experienced by health-care workers during the COVID-19 pandemic often present serious ethical challenges.

Yale-developed scorecard promotes better clinical trial data sharing
A tool developed by researchers at Yale, Stanford, and Bioethics International can promote greater sharing of clinical trial data by pharmaceutical companies.

Digging into new ethical issues around stem cells
Discussions concerning to the ethical issues related to stem cells have been ongoing for many years, but a special section in the latest issue of Perspectives in Biology and Medicine takes a deep look at some of the newest and most complex issues -- including the direct global sales of services and untested and unproven products marketed as stem cells.

The big ethical questions for artificial intelligence in healthcare
AI in healthcare is developing rapidly, with many applications currently in use or in development in the UK and worldwide.

Coding at birth: Nuffield Council on Bioethics publishes briefing note on whole genome sequencing of babies
The Nuffield Council on Bioethics has today published a briefing note that examines the ethical issues raised by whole genome sequencing of babies.

Insight into the challenges and contributions of nurse bioethicists
Nurse bioethicists are a small but special subset of the nursing profession and bioethics community, focusing on the moral complexities that arise in clinical care, research, and health policy.

Data indicate significant impact of NIH African bioethics training programs
A study published in BMJ Open looks back on 10 bioethics training programs funded by the Fogarty International Center at the US National Institutes of Health.

Johns Hopkins bioethics scholar elected to National Academy of Medicine
Jeffrey P. Kahn, PhD, MPH, the Andreas C. Dracopoulos Director of the Johns Hopkins Berman Institute of Bioethics, has been elected to the National Academy of Medicine.

Assessing the intangible
Bioethics scholars at Johns Hopkins create a checklist to help assess respect and patient dignity in the ICU.

Read More: Bioethics News and Bioethics Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.